C.difficile produces two different toxins that constitute the essential virulence factors for CDI induction. Recent investigations have proven that each of the two alone will induce disease in hamsters. C.difficile infection is considered responsible for approximately 25% of the diarrhoea incidents related to the consumption of antibiotics such as clindamycin, second and third generation cephalo sporins, gyrase-inhibitors, ampicillin or amoxicillin. In addition to the diarrhoea symptoms, the disease can lead to pseudo-membranous colitis (PMC), requiring urgent treatment with antibiotics effective against C.difficile and which, without treatment, may severely compromise the life of the patient. CDI mortality can be as high as 6% to 30%, particularly when the patient suffers from PMC. Patients suffering from CDI induced by previous treatment can lead to an increased hospital stay of 6-10 days at an additional cost of 6,000-8,000 Euro.

Principle Of The Test

Rapid C.difficile Toxin A+B test employs a combination of:

1) Red latex particles conjugated to a specific toxin A antibody that cooperates with another antibody specific for toxin A and that is located on the membrane, below the control band.

2) Other red latex particles conjugated to a specific toxin B antibody that cooperates with another specific toxin B antibody that is located on the membrane, above the control band.

3) Blue latex particles conjugated to an antigen recognised by an antibody specific for that antigen and bound to the membrane, serving as the control band test. To run the test, the sample is first treated with a sample diluent buffer (provided in the kit) that extracts the toxins from the stool matrix. Following extraction, an aliquot of the supernatant needs to be added to the test strip by a 15 minute wait. When the extract flows through the test membrane, the coloured particles begin to migrate. In the event of a positive sample, the specific antibodies on the membrane will capture antigen-covered coloured particles. The pattern of lines obtained after 15 minutes of incubation at room temperature are used to interpret the result.